A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes

What this study is about

The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).

Who can join (things the study team will check)

✅ You may be able to join if…

• Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
• Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.
• Body mass index (BMI) ≥27.0 kg/m\^2
• History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight

🚫 You may not be able to join if…

• History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening
• Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening
• At least 2 confirmed fasting blood glucose values >270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening
• Self-reported change in body weight >5 kg within 3 months prior to screening
• Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
• Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
• Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
• Poorly controlled hypertension at screening
• Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure
• Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization

Where this trial is running

• Lakeview Clinical Research, Guntersville, Alabama, United States
• Arizona Clinical Trials, Tucson, Arizona, United States
• Orange County Research Center, Lake Forest, California, United States
• Ark Clinical Research, Long Beach, California, United States
• Catalina Research Institute, LLC, Montclair, California, United States
• Infinity Clinical Research, Norco, California, United States
• Prospective Research Innovations Inc., Rancho Cucamonga, California, United States
• Encompass Clinical Research, Spring Valley, California, United States
• Emerson Clinical Research Institute, Washington D.C., District of Columbia, United States
• Tampa Bay Medical Research, Inc., Clearwater, Florida, United States
• Center for Diabetes, Obesity and Metabolism Inc, Pembroke Pines, Florida, United States
• Progressive Medical Research, Port Orange, Florida, United States

+ 110 more sites.

Who to contact

Reference Study ID Number: WC45726 https://forpatients.roche.com/ No attachments to email below. · 888-662-6728 (U.S. Only) · global-roche-genentech-trials@gene.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07351058.